Conventionally, chemical manufacturing applications are executed within reusable stainless steel systems. However, single-use (e.g., disposable) technology (SUT) and in particular, single-use systems (SUS) such as bags or the like are a fast growing technology innovation for the biotechnology and biopharmaceutical manufacturing markets. SUS are used in a wide variety of biopharmaceutical manufacturing applications (both upstream and downstream applications), particularly in clinical testing and research and development.
SUS offers several advantages over conventional reusable stainless steel systems by reducing contamination risk, reducing the amount of cleaning time and chemicals required for each process, and reducing the number and/or complexity of necessary system validation steps. Some additional benefits of employing SUS include flexibility, scalability, and speed of implementation.
Accordingly, SUS are presently deployed in systems ranging from bioreactors to mixing systems. Examples of upstream applications that currently use SUS include media preparation processes such as mixing, clarification, and sterilizing filtration. Examples of downstream applications that currently use SUS include cell harvesting, clarification, chromatography concentration and diafiltration, contaminant removal, and buffer preparation.
The control of such processes requires accurate measurements of a number of process parameters, including, for example, the temperature or concentration of the chemicals involved in the process. As such, with the growing use of SUS it is desired to measure these process parameters in conjunction with these SUS. Doing so, however, has not proved straightforward or effective. In no small part efforts to do so have been frustrated by the fact that sensors must be integrated with the SUS. It is difficult to interface a sensor with containers used in SUS, such as a bag, and still obtain accurate measurements. In no small part this may be because certain sensors may need to contact the chemical itself to obtain an accurate measurement or may measure parameters indirectly (e.g., measure a proxy for a parameter). Additionally, the cost of such sensors is problematic. When an instance of a process is completed, the SUS may be disposed of, including the sensor. As the sensors may be expensive, the constant disposal of such sensors may increase the costs of manufacturing the chemicals using such SUS.
What is desired then, are systems and methods to effectively integrate sensors into SUS to improve data collection for use in process control or management. It is especially desired to provide effective and relatively low cost systems and method for effective chemical concentration or temperature measurement in these SUS.